Phase 3 Hepatitis C Trial, Completed NCT01485991 Sponsor: Janssen R&D Ireland Condition: Hepatitis C
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 385 people in the simeprevir group and 386 people in the telaprevir group — a total of 771 participants — all of whom had hepatitis C. The trial was comparing two different antiviral medicines (simeprevir and telaprevir), each given alongside two other standard medicines (peginterferon alfa-2a and ribavirin). The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood and stayed that way for at least 12 weeks after treatment finished — a result known as SVR12 (sustained virologic response at 12 weeks). The reported data shows that 53.6% of participants in the simeprevir group and 54.7% in the telaprevir group met the SVR12 measure — meaning the virus was undetectable in their blood at that point. For a similar measure taken 24 weeks after treatment ended (SVR24), the reported figures were 53.3% for the simeprevir group and 55.2% for the telaprevir group. The trial also tracked how many participants had the virus return after initially becoming undetectable — this is called viral relapse. The reported data shows a relapse was recorded in 17.9% of the simeprevir group and 16.4% of the telaprevir group. It is worth noting that 32 people in the simeprevir group and 36 in the telaprevir group did not complete the study, though the reasons for this were not detailed in the data provided here. No other outcome figures beyond those described above were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Hepatitis C Trial, Completed

NCT01485991
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have had a liver biopsy before or around the time of screening, unless a biopsy is not possible for you or you have signs of increased blood pressure in the liver not caused by scarring — in those cases, a recent (within 6 months) non-invasive liver scan or blood test result is needed instead
  • You must have had hepatitis C for at least 6 months, confirmed by a blood test showing hepatitis C antibodies and/or the virus itself, or by scarring seen on a liver biopsy
  • You must have the specific "genotype 1" strain of hepatitis C, with a virus level above 10,000 IU/mL in your blood — both confirmed at screening
  • You must have already tried at least one full course of a specific combination treatment (pegylated interferon alfa-2a or alfa-2b with ribavirin) for at least 12–20 weeks, depending on how your body responded to it

Who may not be able to join:

  • People whose liver is no longer functioning well, shown by significant abnormal test results or other active liver-related health problems
  • People who also have HIV, or who have a strain of hepatitis C other than genotype 1
  • People whose liver disease is caused by something other than hepatitis C
  • People who have previously been treated for hepatitis C with anything other than pegylated interferon and ribavirin

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Tibotec Pharmaceuticals Limited Clinical Trial, Tibotec Pharmaceutical Limited

Australian sites

, Darlinghurst,
, Greenslopes,
, Kingswood,
, Melbourne,
, Parkville - Vic,
, Perth,
, Sydney,
, Woolloongabba,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Janssen R&D Ireland
Registry
ClinicalTrials.gov
Start date
1 February 2012
Est. completion
1 April 2014

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov